N-Nitroso Desmethyl Tramadol

New Scientific Knowledge & Development
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I hope this message finds you well.

First and foremost, I would like to express my sincere gratitude for the valuable knowledge sharing and the exceptional platform you have provided for continuous exchange and learning. It has been instrumental in enhancing our understanding of key scientific and regulatory matters.

I am reaching out to discuss the generation of N-Nitros Desmethyl Tramadol, which is listed in the EMA guidance. Based on our current assessments and the review of available literature, we believe there is a potential to justify its presence through a comprehensive paper-based assessment. We would appreciate the opportunity to explore this further within team.

i am keen to discuss the feasibility of this approach, as well as any specific considerations that may need to be addressed to ensure that the justification aligns with regulatory expectations. Your insights and guidance in this matter would be invaluable, and I look forward to a collaborative discussion on how best to proceed.

Thank you once again for fostering such a rich environment for knowledge exchange, and we look forward to hearing your thoughts.

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Hi, is there any scavenger or control mechanism for N- Nitroso desmethyl tramadol?

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I would agree. As soon as you see a regulatory limit & find a standard from a reputable source, that should be enough information to confirm the risk.

Many have found that controlling the des-methyl impurity in the incoming API for dimethyl tertiary amines is critical. That reaction mechanism is significantly faster than the full reaction from the API itself.

You will want to test your product at various ages. I would suggest a method that quantifies both the nitrosamine and the des-methyl API.

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Totally agree with that.

For this specific type of nitrosamine with an aromatic group there is also the competition N-nitrosation vs. C-nitration which can be different for the tertiary vs. the secondary amine.

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